Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
IDIPV
Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
1 other identifier
interventional
231
1 country
1
Brief Summary
The purpose of this study is to determine whether a lower dose of inactivated polio vaccine (IPV) injected into the skin (intradermal administration) can work equally well or better than the standard dose injected into the muscle (intramuscular administration). There are more immune cells in the skin than in the muscle, and other vaccines have been shown to require a lower dose when administered intradermally. The study is being done in participants infected with HIV because HIV-infected people are known to respond less well to vaccines than other groups, so it is particularly important to know if IPV might work better in HIV-infected people if administered intradermally. If it is possible to lower the dose of IPV by intradermal administration, this would make inactivated polio vaccine more affordable in the developing countries where it is most needed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
February 5, 2015
CompletedFebruary 5, 2015
January 1, 2015
11 months
September 13, 2012
January 13, 2015
January 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Post Booster Polio Neutralizing Antibody Titers
Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.
4-6 weeks after receiving the vaccine
Secondary Outcomes (1)
Baseline Polio Neutralizing Antibody Titers
first visit
Study Arms (4)
2/5 dose intradermal IPV
EXPERIMENTALParticipants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
1/5 dose intradermal IPV
EXPERIMENTALParticipants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
full dose intramuscular IPV
ACTIVE COMPARATORParticipants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
2/5 dose intramuscular IPV
ACTIVE COMPARATORParticipants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
Interventions
Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
Eligibility Criteria
You may qualify if:
- documented HIV infection
- age of at least 18 years old
- HIV viral load \<400 on the most recent test
You may not qualify if:
- current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit, shortness of breath, altered mental status, or by judgment of the primary clinician)
- current pregnancy
- history of allergic reaction to a polio shot,
- history of a life-threatening allergic reaction to neomycin, streptomycin, or polymyxin B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eastern Virginia Medical Schoollead
- NanoPass Technologies Ltdcollaborator
Study Sites (1)
C3ID Clinic, Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Related Publications (1)
Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. 2015 Jun 15;211(12):1969-76. doi: 10.1093/infdis/jiu841. Epub 2015 Jan 7.
PMID: 25567841RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.
Results Point of Contact
- Title
- Dr. Stephanie Troy
- Organization
- Eastern Virginia Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie B Troy, MD
Eastern Virginia Medical School
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
September 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
February 5, 2015
Results First Posted
February 5, 2015
Record last verified: 2015-01